Identity
- Trade Name
- ADVIA Centaur® COR +E FDA UDI
- Generic Name
- Total cortisol IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Cortisol - CENTAUR - RGT - 250 tests FDA UDI
- Model / Reference
- 10321026 FDA UDI
- Description
- Cortisol - CENTAUR - RGT - 250 tests FDA UDI
Identifiers
- Catalog Number
- 4610138 FDA UDI
- Primary DI / UDI-DI
- 00630414524610 FDA UDI
- 510(k) Number
- K962559 FDA UDI
- FDA Product Code
- JFT FDA UDI
- GMDN Term
- Total cortisol IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1205 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total cortisol IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® COR +E by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total cortisol IVD, kit, chemiluminescent immunoassay.
- IMMULITE® 2000 Systems COR Cortisol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- Cortisol AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- Elecsys Cortisol II — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
- IMMULITE® 2000 Systems COR Cortisol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 0a9d0fd6-b536-4821-b234-8398d2f7cdc4 37 fields · synced Jun 1, 2026